Recruiting

Phase 2

PST vs. LaserPST/Laser v. Laser Alone for CSME

Sponsor:

Edward Hines Jr. VA Hospital

Code:

NCT00229918

Conditions

Diabetic Retinopathy

Eligibility Criteria

Sex: Male

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

triamcinolone acetonide

Study Details

Brief summary:

Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon injection of triamcinolone acetonide for primary and refractory clinically significant macular edema.

Conditions

Diabetic Retinopathy

Study ID

NCT00229918

Start date

Sep, 2005

Status verified date

Sep, 2005

Completion date

Sep, 2006

Eligibility Criteria

Sex: Male

Age: 25 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

The criteria listed below must be satisfied in order for the patient to be eligible for the study.

Age 25 to 80, inclusive.
Primary CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with no previous history of focal/grid laser photocoagulation.
Refractory CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with at least one session of focal/grid laser photocoagulation. Additionally, the eye must have a central macular thickness of at least 300 μM (normal, 200 μM) as measured by OCT and vision loss from baseline.

All patients in the Hines VA Eye Clinic with suspicion of CSME will be referred to the Hines VA Retina Clinic where they will be evaluated by a Retina specialist (Dr. De Alba) and where the diagnosis of CSME will be confirmed by clinical examination and fluorescein angiography.

Exclusion Criteria:

If any of the exclusion criteria listed below is/are present, the patient will not be eligible for the study.

Unwilling or unable to give consent.
Unable to return for scheduled follow-up visits.
No light perception, light perception, count fingers, or hand motion vision.
History of glaucoma (any form).
History of ocular hypertension.
History of IOP elevation with ocular and/or systemic steroid treatment.
Baseline IOP greater than 22 mmHg.
All patients with IOP elevation greater than 22 mmHg following treatment with topical prednisolone acetate.
All patients with IOP elevation greater than 5 mmHg from baseline measurement following treatment with topical Prednisolone acetate.
Advanced proliferative diabetic retinopathy.
History of retinal detachment in either eye.
Any ocular disease (anterior or posterior segment) obstructing the view of the fundus (i.e., dense cataract, vitreous hemorrhage).
History of PST or intravitreal triamcinolone acetonide injection in either eye six months prior to the study.
History of 20/200 vision or worse from any cause in the fellow eye.
Active inflammatory, infectious, or idiopathic keratitis.

Study Design

Enrollment

60 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

triamcinolone acetonide

Primary outcome measure

Vision loss [ Time Frame: undefined ]
Vision gain [ Time Frame: undefined ]
Central macular thickness [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Felipe de Alba, MD

(708) 202-2061 fdealba@lumc.edu

Anuradha Khanna, MD

(708) 202-2061 akhanna@med.va.gov

Locations

Edward Hines Jr. VAH

Recruiting

Hines, Illinois, United States, 60141

Contacts

Anuradha Khanna, MD

708-202-2061 akhanna@med.va.gov

Principal Investigator:

Felipe de Alba, MD

More Information

Sponsor

Edward Hines Jr. VA Hospital

Last update posted

Sep 30, 2005

Last verified

Sep, 2005

Keywords

Diabetic macular edema
Clinically significant macular edema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Edward Hines Jr. VA Hospital on 2005-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.